Pfenex Inc. (NYSE AMERICAN: PFNX) and China NT Pharma Group Company Limited (NT Pharma) (HKG:1011) today announced an agreement under which Pfenex granted NT Pharma non-exclusive development and exclusive commercialization rights to PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly & Company's Forteo®, in Mainland China, Hong Kong, Singapore, Malaysia and Thailand.
Forteo®(Teriparatide) : Eli Lilly And Company v. Apotex
Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide).
Eli Lilly and Company (NYSE: LLY) today announced new data showing that treatment with FORTEO® for 24 months was associated with significantly fewer vertebral and clinical fractures (a composite of painful vertebral and non-vertebral fractures) compared with risedronate, a widely used oral bisphosphonate, in postmenopausal women with severe osteoporosis in the VERO clinical trial. Study results are published in the November 9 issue of The Lancet.1
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Gedeon Richter Terrosa (Teriparatide) Receives Approval In Europe
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The company said it will use the funds to complete Phase I clinical trials of the product during 2017, following on from a successful preclinical proof-of-concept study, in which the solid dose formulation achieved a statistically similar pharmacokinetic profile to the most widely used clinical dose of the marketed liquid product, Forteo/Forsteo.
Nine therapies spanning a range of diseases have been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use, including three biosimilars.